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Clinical Trials/NCT06354907
NCT06354907
Active, Not Recruiting
N/A

Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)

University of Michigan1 site in 1 country120 target enrollmentOctober 3, 2022

Overview

Phase
N/A
Intervention
The Kids' Empowerment Program
Conditions
Child Mental Disorder
Sponsor
University of Michigan
Enrollment
120
Locations
1
Primary Endpoint
Strengths and Difficulties Questionnaire
Status
Active, Not Recruiting
Last Updated
2 months ago

Overview

Brief Summary

Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.

Detailed Description

The aim of this clinical trial is to conduct an evaluation of whether children who participate in the Kids' Empowerment Program (KEP) have fewer symptoms of depression and anxiety after 12 weeks relative to those in the comparison group. Further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. The experimental condition consists of both those who experience the KEP in-person in their classroom (n = 60) and 60 in the comparison condition. Standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. Those in the comparison group receive the KEP program in their classroom after the second interview. Children are interviewed at school and parents complete an online survey.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
October 2, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sandra A Graham-Bermann

Professor of Psychology, College of Literature, Science, and the Arts and Professor of Psychiatry, Medical School

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Child age 6 to 12 years
  • Parent consents to participate interviews and the program
  • Parent agrees to two assessments

Exclusion Criteria

  • Child age younger than 6 and older than 12
  • Child with significant developmental or cognitive delays prohibiting program participation

Arms & Interventions

The KEP Group

Children in the KEP group will be interviewed before and after participation in the 12 weeks Kids' Empowerment Program in their classroom. Their parent will complete an online assessment via survey software before their child begins the program and again after 12 weeks.

Intervention: The Kids' Empowerment Program

The Comparison Group

Children in the comparison group will be interviewed once and again 12 weeks later. Their parent will complete an online assessment once and again 12 weeks later. Children in the Comparison group will then participate in the Kids' Empowerment Program in their classroom.

Outcomes

Primary Outcomes

Strengths and Difficulties Questionnaire

Time Frame: Pre-intervention and 12 weeks later

Parent reported and child self-rated aggression, peer problems, and pro social skills - 15 items (5 items each scale). Scoring ranges from 0 to 2. Minimum score for each scale is 0 and maximum score if 10. Higher scores indicate greater aggression, greater peer problems, and greater prosocial behavior.

Revised Children's Anxiety and Depression Scale

Time Frame: Pre-intervention and 12 weeks later

Parent reported and child self-rated symptoms of child's anxiety and depression - 25 items, scored 0 to 3, with minimum score of 0 and highest score of 75. Higher scores indicate greater anxiety and depression.

Secondary Outcomes

  • Cognitive Emotion Regulation Questionnaire(Pre-intervention and 12 weeks later)

Study Sites (1)

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